Purpose of Training:
Explaining and interpreting the ISO 13485 quality management system standard for medical device industry managers. To gain the requirements of the role of the standard in CE certification.
Content of the Training:
•What is ISO 13485 Standard?
•Quality Management System Benefits for Medical Devices
•Quality Management Principles and Process Model
•Compliance with Other Standard Management Systems and Medical Devices CE Directive
•Risk Management
•Reinforcement of ISO 13485 conditions in medical device production with examples,
•Establishing the connection between legal conditions and standard requirements
•To have general knowledge about the establishment of ISO 13485 Quality System.
Participant Profile: Company managers and owners who want to manage in accordance with Quality Systems and obtain CE Certificate, quality officers who want to have the qualifications to implement, develop and manage these systems, and human resources and company personnel who want to have a career in quality can participate in these trainings.
Exam: Exam can be taken at the end of the training.
Trainer: Provided by our International Chief Auditor and Training Experts. Announced Before Training.
Training Date: Announced Before Training.
Training Duration: 1 or 2 days.
Training Location: Our Company Training Halls or Announced Before the Training.
Certificate: At the end of the training, a certificate is given to those who attended the training.
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English